Protocolized Sedative Weaning VS. Usual Care in Pediatric Critically Ill, RCT

April 10, 2018 updated by: Nattachai Anantasit, Ramathibodi Hospital

Protocolized Sedative Weaning Versus Usual Care in Pediatric Critically Ill, Randomized Controlled Trial

Sedative and analgesic agents are widely used in the ICU. These agents can provide hypnotic effect, pain alleviation, cooperation, and synchronizing ventilatory support. Prolonged use of the agents can lead to withdrawal symptoms when the drugs are weaned.

Prior study showed the longer duration of sedative drugs, cumulative dose of medications and younger age were the risk factors of withdrawal syndrome. Additional, some study showed the sedation protocol can reduce the incidence of withdrawal syndrome. However, no worldwide standardized sedative weaning protocol including our hospital. The objectives in this study are to establish the sedative weaning protocol and to compare the protocol sedative weaning with the usual care weaning.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sedative and analgesic agents, particularly benzodiazepines and opioids, are widely used in PICU. These agents can provide calmness, hypnotic effect, pain alleviation, cooperation, immobilization and synchronizing ventilatory support.

Prolonged use of the agents can lead to withdrawal symptoms when the drugs are weaned.

Incidence of withdrawal syndrome is about 50%. Withdrawal syndrome can lead to unnecessary and costly diagnostic tests, prolongation of mechanical ventilation and hospital stay, and increasing of suffering. Prior study showed the longer duration of sedative drugs, cumulative dose of medications and younger age were the risk factors of withdrawal syndrome. Additional, some study showed the sedation protocol can reduce the incidence of withdrawal syndrome. However, no worldwide standardized sedative weaning protocol including our hospital.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Department of Pediatric,Ramathibodi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 1 mo to 18 yrs, at least 37 week of postmenstrual age
  • Patient who was admitted in PICU or intermediate ward at Ramathibodi hospital
  • use analgesic/sedative drugs (parenteral)≥ 3 days

Exclusion Criteria:

  • Patients in whom level of sedation or withdrawal assessment cannot be scored.
  • Patients transferred from other hospitals in which the patients have already presented of withdrawal symptoms
  • patient/parent refuse this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Sedative weaning protocol
We create the new sedative weaning protocol and then use the sedative weaning protocol.
Other: The sedative weaning protocol group
After physician decide to wean sedative or analgesic drugs. We divided to 2 groups including high risk group and low risk group. The sedative weaning protocol were used in these patients which rely on the high risk or low risk group.
PLACEBO_COMPARATOR: Usual Care
no use sedative weaning protocol. Sedative or/and analgesic medications are adjusted base on physician
Other: The usual group
After physician decide to wean sedative or analgesic drugs. The sedative/analgesic drugs were weaned depend on physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of withdrawal symptom
Time Frame: 72 hour
72 hour

Secondary Outcome Measures

Outcome Measure
Time Frame
length of PICU stay
Time Frame: 30 days
30 days
sedation related adverse events
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramathibodi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (ACTUAL)

March 1, 2018

Study Completion (ACTUAL)

April 1, 2018

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (ESTIMATE)

January 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2018

Last Update Submitted That Met QC Criteria

April 10, 2018

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID125808

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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